Commentary on Payment and Reimbursement Issues Affecting the Marketing of Drugs, Medical Devices, and Biologies, with Emphasis on the Anti-Kickback Statute and Stark II

摘要

When a manufacturer considers bringing a new drug, medical device, or biologic to market, two fundamental questions are who will use it and who will pay for it. Typically, who will use the product is resolved during product development. This article focuses on the question of who will pay and the terms of payment. Because most patients likely to use a new drug, medical device, or biologic usually are covered by health insurance or other third-party payor programs, a manufacturer needs to examine which insurers or third-party payors cover the group that will use the new product in question. If it will be used primarily by the aged population, the major concern is Medicare's coverage and payment regulations. If it is a product aimed at children, the major concern is the state medical assistance programs (Medicaid) and private insurance. Each health insurer or third-party payor has different rules concerning whether and how it will include new drugs, medical devices, or biologies in its program, and each has different payment requirements and standards. Because the number of insurance, managed care, and government payment programs is so large, this article will focus on the Medicare and Medicaid requirements, which tend to set the standard for otherpayors. Not all the issues covered here, however, are relevant to all insurers or payors, and issues not covered here may arise, so counsel should be consulted about transactions involving any particular drug, medical device, or biologic.